Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease

January 10, 2019 updated by: University of Zurich

Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease

The aim of the present study is to investigate whether the ingestion of a cocoa flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and platelet function in patients with overt coronary artery disease acutely (after 2 hours)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Cardiovascular Center Cardiology Univeristy Hospital of Zurich
      • Zurich, Switzerland
        • Universisty Hospital of Zurich, Cardiovascular Center Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention

  • Age 20 - 80
  • Written obtained informed consent

Exclusion Criteria:

  • Acute ST-elevation myocardial infarction
  • Acute non-ST-elevation myocardial infarction (enzyme positive)
  • Ventricular tachy-arrythmias or AV-Block >I°
  • Renal insufficiency (GFR MDRD < 30ml/min) or liver disease (ALT or AST >150 IU)
  • Pregnancy
  • Known allergy to compounds of cocoa product
  • Known allergy to contrast media
  • Known allergy to nuts
  • Intolerance to coffein and theobromin
  • Acute infectious disease
  • Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
  • Participation in another study within the last month
  • Concomitant vitamin supplements and herbal remedies, as well as fruit and tea extracts
  • No study visits ± 1 week before Eastern, Christmas and New Year holyday (altered eating habits)
  • Extreme eating habits (as assessed by a questionnaire)
  • Alcohol or drug abuse
  • Lactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: flavanol-containing drink
Dietary supplement: flavanol-rich drink vs flavanol-free drink
Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content
Placebo Comparator: flavanol-free drink
flavanol-free drink matched for taste and calories
Dietary supplement: flavanol-rich drink vs flavanol-free drink
Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coronary endothelial function as assessed as response to cold pressor test
Time Frame: 2 hours

Primary endpoint will be the improvement in coronary endothelial function in response to cold pressor testing (i.e. % reduction in coronary artery constriction compared to baseline) 2h after ingestion of a cocoa flavanol rich-drink or placebo drink, respectively.

In a subset of patients daily consumption of a flavanol-drink will be assessed and outcomes measured after 3-4 weeks.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Thomas F Lüscher, Prof MD, University Hospital Zurich, Cardiovascular Center Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK2012-0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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